Examining the Cognitive Benefits of Cardiac Rehabilitation in People With Heart Failure (The CHF CaRe Study)

NCT ID: NCT00871897

Last Updated: 2016-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-06-30

Brief Summary

People with heart failure may experience problems with cognitive function, including memory and attention. Cardiac rehabilitation, which is an individualized program for heart failure patients that aims to improve their heart health, may also improve cognitive function. This study will examine the relationship between heart failure and cognitive function and how undergoing cardiac rehabilitation affects cognitive function in older adults with heart failure.

Detailed Description

Over 5 million people in the United States have heart failure, and 500,000 more develop this condition each year. Up to 80% of people with heart failure experience cognitive functioning difficulties, including problems with memory, attention, and other thinking skills. People with heart failure often participate in a cardiac rehabilitation program, which is an individualized program that aims to improve a person's physical and mental health while dealing with a heart-related condition. Cardiac rehabilitation is different for each person, but it can include medical counseling on how to manage a heart condition and how to modify risk factors for further heart problems, including lowering blood pressure and cholesterol levels, stopping smoking, and losing weight. Nutritional counseling and an exercise program may also be a part of cardiac rehabilitation. Preliminary research has shown that people with heart failure who participate in a cardiac rehabilitation program may experience improved cognitive function. This is thought to be a result of increased blood flow to the brain and improved autonomic nervous system function, which is responsible for regulating various body functions. In this study, researchers will explore the relationship between heart failure and cognitive function, examine how cognitive function changes over time in heart failure patients, and evaluate how cardiac rehabilitation may affect cognitive function in older adults. Specifically, researchers will examine how physical activity and patterns of blood flow affect cognitive function.

This study will enroll people with heart failure who are participating in a 12-week cardiac rehabilitation program and people with heart failure who are not participating in a cardiac rehabilitation program. All participants will attend study visits at baseline, Week 12, and Month 12. At each study visit, participants will undergo neuropsychological testing, heart rate and blood pressure measurements, and a walking exercise test. They will also complete questionnaires to assess diet, physical activity, and stress levels. Participants will undergo an imaging procedure to measure blood flow in the neck and head, and some participants will also undergo a magnetic resonance imaging (MRI) procedure of their brain. For 1 week after each study visit, participants will wear a physical activity monitor. At Months 6 and 9, participants will complete questionnaires and mail these back to study researchers.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Conditions

Heart Failure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cardiac Rehabilitation

People with heart failure who elect to participate in cardiac rehabilitation.

No interventions assigned to this group

No Cardiac Rehabiliation

People with heart failure who elect NOT to participate in cardiac rehabilitation.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Systolic heart failure confirmed by perfusion stress scan

Exclusion Criteria

• Has a pacemaker

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Responsible Party

Kent State University

Principal Investigators

John Gunstad, PhD

Role: PRINCIPAL_INVESTIGATOR

Kent State University

Locations

Summa Health System

Akron, Ohio, United States

Countries

United States

References

Walter FA, Gathright E, Redle JD, Gunstad J, Hughes JW. Depressive Symptoms are Associated with Heart Rate Variability Independently of Fitness: A Cross-Sectional Study of Patients with Heart Failure. Ann Behav Med. 2019 Oct 7;53(11):955-963. doi: 10.1093/abm/kaz006.

Reference Type: DERIVED

PMID: 30958884 (View on PubMed)

Alosco ML, Spitznagel MB, van Dulmen M, Raz N, Cohen R, Sweet LH, Colbert LH, Josephson R, Hughes J, Rosneck J, Gunstad J. Cognitive function and treatment adherence in older adults with heart failure. Psychosom Med. 2012 Nov-Dec;74(9):965-73. doi: 10.1097/PSY.0b013e318272ef2a. Epub 2012 Oct 31.

Reference Type: DERIVED

PMID: 23115344 (View on PubMed)

Other Identifiers

R01HL089311

Identifier Type: NIH

Identifier Source: secondary_id

View Link

649

Identifier Type: -

Identifier Source: org_study_id